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About Rhophylac
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Important Saftey Information
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About Rhophylac®

Rhophylac® is a sterile solution of anti-D, also known as Rho(D) Immune Globulin or Rh factor, which affords protection from Rh-sensitization or alloimmunization. Rhophylac® can be administered by intravenous (IV) or intramuscular (IM) injection.

Rhophylac® is made from human source plasma collected from US donors using a patented manufacturing process called ChromaPlus™ . This unique manufacturing process not only helps minimize the risk of viral transmission, but also uses ion-exchange chromatography, a crucial element in delivering the purity to allow both intramuscular and intravenous administration by eliminating virtually all foreign aggregates from the source plasma.

Each syringe contains a minimum of 1500 IU (300 mcgs) of IgG antibodies to Rho(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs. Treatment consists of 2 doses: first at 28 to 30 weeks' gestation if the mother is Rh-negative and again within 72 hours after delivery if the baby is Rh-positive. For Rh-negative women who are pregnant, this protection is essential in thwarting the development of hemolytic disease of the newborn (HDN).

This interactive video provides essential information on CSL Behring, HDN, and Rhophylac®, including:

  • A demonstration on administration
  • A description of manufacturing, dosage, and packaging
  • Answers to frequently asked questions
Rhophylac<sup>®</sup> In-Service Video


© CSL Behring 2008. The product information on this site is intended for US residents only.

Important Safety Information

Rhophylac® is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rho(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
  • Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.

For suppression of Rh isommunization, Rhophylac® can be administered IM or IV.

Rhophylac® is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products.

Allergic or hypersensitivity reactions may occur with Rhophylac®; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

Rhophylac® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

For postpartum use following an Rh-incompatible pregnancy, Rhophylac® should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac® are nausea, dizziness, headache, injection-site pain, and malaise.

Please see full prescribing information.